5
Procurement & Supply Chain Management
5
Procurement & Supply
Chain Management
IATT Toolkit, Expanding and Simplifying Treatment for Pregnant Women Living with HIV: Managing the Transition to Option B/B+ | www.emtct-iatt.org
1
5
Procurement & Supply Chain Management
5.1 Introduction
In many respects, a switch to Option B/B+ represents a move to greater efficiency and
simplification in the supply chain:
“[In Option B/B+] the ability to use the same regimen for PMTCT and for first-line
ART considerably simplifies drug forecasting, procurement, supply to facilities,
and drug stock monitoring. The first-line regimen of tenofovir/lamivudine/efavirenz
(TDF/3TC/EFV) is available as a single-pill fixed-dose combination and has been
recommended recently as the optimized regimen for first-line adult treatment,
including for pregnant women.b”
Option B+ provides even further advantages in terms of streamlining and simplifying the
supply chain, as it does not require CD4 testing to determine ART eligibility (as in Option
A) or whether ART should be stopped or continued after risk of MTCT has ceased (as in
Option B). As early evidence in Malawi has demonstrated – with a nearly fivefold increase
in the numbers of pregnant women enrolled on ART in the first quarter of nationwide
implementation – there are many benefits to the one-size-fits-all, integrated approach of
Option B+. Likewise, as demonstrated in Malawi, roll-out of Option B+ has meant rapid
scale-up and a major change from the previous service delivery model, which has created
both opportunities and challenges.
Maintaining ongoing commodity security for women and their children is of utmost importance as this transition is made. Despite the many ways in which implementing Option
B+ can radically simplify and harmonize supply chains, it is nonetheless a major change
that does require some additional considerations. Not least of which is the additional
funding required to purchase the increased volume of ARVs, particularly as countries
integrate the ART and PMTCT systems in country, as part of the move to Option B+.
Procurement & Supply Chain Management
This tool provides some key questions to consider and resources for national
decision-makers, program managers, consultants and implementing partners involved
in logistics and supply chain to use when planning the implementation of Option B+.
2
b
“WHO Programmatic Update: Use of Antiretroviral Drugs for Treating Pregnant Women and Preventing HIV Infection in Infants”,
April 2012, http://www.who.int/hiv/PMTCT_update.pdf
5
5.2 Key PSCM questions to ask when
planning the implementation of Option B+:
Once Option B+ is adopted as national policy, it is recommended that HIV positive pregnant women are treated as part of the general ART programme and stock levels of ART for
pregnant women living with HIV monitored as part of the national procurement and supply
management (PSCM) system. Currently and increasingly, as countries transition to Option
B+, the provision of ART for HIV positive pregnant women occurs in MNCH settings,
underscoring the need to strengthen PSCM for MNCH commodities and promote integration of the national MNCH and ART programme, where feasible.
Once Option B+ is adopted as policy, the quantification of ARV needs should include
all pregnant women as part of the larger population eligible for ART. Pregnancy actually becomes a criteria for ART eligibility and should not be a cost outside of the ART
programme. Partners wishing to contribute to support Option B+ can join the national
basket fund and the planning group. For more information on costing ARV drugs for
EMTCT the costing tool is useful if EMTCT has a starting point and an ending point. In the
case of Option B+, ART use in pregnant women becomes a recurrent cost.
Funding
• Has a costing exercise been completed so that the additional costs of Option B+ are
fully quantified and understood?
• Are sufficient funding sources currently available to provide for the additional costs of
B+ implementation?
• Who are the partners and what is their role in financing PMTCT and
MNCH commodities?
• Questions to consider while gathering the inputs for the quantification:
◦◦ How will alternative regimens be incorporated into the quantification?
◦◦ What is the refill strategy at the facility level (monthly, quarterly)?
◦◦ What assumptions are being made as regards to scale-up and speed of switch
over to Option B+?
Procurement & Supply Chain Management
Quantification
3
5
• Are national forecasts conducted for all EMTCT commodities, and if so, how
frequently? An annual quantification and forecast is recommended with quarterly
review to take account of actual consumption and to enable adjustment of upcoming
orders as necessary.
• Are health facilities submitting complete and reliable commodity consumption and
service delivery data on a timely basis? If not, what proxy data can be used in quantification and forecasting?
• Is consumption or distribution data used for forecasting and ordering of
EMTCT commodities?
• Is the current EMTCT forecasting process a part of the general ART forecasting
process in the country? If not, what are the plans to integrate these processes?
• Which tool is currently used for EMTCT commodity forecasting?
Procurement and supply concerns
• In order to prevent excess wastage, what is the plan to use up current existing
commodities that will no longer be needed when Option B+ is rolled out?
• Have there been stock-outs of EMTCT commodities in the past 6-12 months?
• Have there been any issues with suppliers in terms of delayed delivery (e.g., with
NVP syrup)?
• How does the country currently tender for and procure EMTCT commodities? Is
there a plan to integrate this process with general ART procurement and tendering in
the country?
Procurement & Supply Chain Management
• If you have experienced in-country customs clearance process delays, can you order
further in advance or use other strategies to mitigate this risk?
4
• If new commodities or increased quantities of currently stocked commodities are
required does the project plan to introduce Option B+ allow sufficient time for the full
realistic procurement and delivery cycle of new orders?
Distribution
• Do all sites that provide commodities for PMTCT also provide ART initiation and ART
refills? If not, how many facilities provide solely PMTCT? In moving to Option B+, are
there plans to expand ART initiation and/or refill services to all sites currently providing only PMTCT commodities?
5
• Are there currently separate systems for distribution of ART and EMTCT commodities? What are your plans to extend the availability of commodities at the point of
service, and limit too many upstream referrals for refills?
• What efforts are being made at the “last mile” of the distribution system, to ensure
that commodities make it out to facilities efficiently?
• Are there opportunities to integrate procurement and distribution of EMTCT
commodities with that of other systems, including contraceptives, immunisations,
etc.? What coordination is happening between the various groups?
• Do systems exist to identify excess stock at sub-distribution point and at facility
level to enable products to be reallocated and moved to areas with higher demand?
Redistribution mitigates the risk of localized stock outs and wastage at points of
lower than expected demand.
Monitoring
• Do PSCM managers at a health facility level monitor consumption and stock levels
and number of patients on EMTCT on monthly basis? A monitoring tool can be
found at the link here: http://www.who.int/hiv/pub/amds/monitoring_evaluation/en/
index.html
• What are the plans for integrating the existing EMTCT M&E systems with those
for ART?
• Are strong systems in place to support adherence and retention, during pregnancy
and postpartum? This becomes particularly critical with Option B+.
Procurement & Supply Chain Management
87
5
5
5.3 High-Level Red Flags
Stock-Outs
If you have experienced stock-outs of any EMTCT commodities in the past 12 months,
you must investigate the cause of the problem – was it an inaccurate quantification?
Poor ordering and reporting from sites? Inefficiencies with distribution at the site level?
Unexpectedly rapid scale-up (which is very likely during roll-out of Option B+)? And
address the problem accordingly.
Supplier delivery delays
For products for which you experience delivery delays, particularly those that are singlesourced, consider increasing the size of your buffer stock for that product during your
next quantification and order cycle, in order to prevent future stock-outs.
Prioritizing pregnant women for ART
It is necessary to conduct sensitisation and advocacy activities to ensure that pregnant
women that do not meet the treatment eligibility criteria for the general adult population
are still prioritized for ART.
Procurement & Supply Chain Management
Conclusion
6
In Option B+, the quantification, PSCM, distribution and monitoring of ARV and other
required specific commodities should be integrated in the national ART programme.
Health professionals working in PMTCT and MNCH should be represented in the various ART technical working groups to ensure that the specific needs of pregnant women
are well addressed. In case the country has a parallel EMTCT system, the above questions raised under quantification, PSCM, distribution, and M&E highlight red flags and
a plan for integrating the national ART programme should be urgently implemented to
prevent a vertical process which may lead to inefficiency and not be sustainable in the
longer term. When integrating the national ART and PMTCT programme, it is important to ensure that all the issues raised above are functioning well in the national PSCM
system to ensure an effective supply chain management for all HIV positive pregnant
women and individuals eligible for ART.
5
5.4 Pre-Implementation Checklist
Guidelines
Updated PMTCT guidelines, training materials and job aids
Guidelines for the management of the new supplies, including stock management,
requesting and reporting tools
Checklists
Checklists for accreditation of health facilities for the implementation of the revised
PMTCT guidelines, including minimum standards of the management of the new
supplies (in terms of availability of appropriate human resources, storage quality,
capacity and security)
Supervision checklists for the pharmaceutical and other health staff, and trainers for
the pilot on the new guidelines and of trainers for the pilot
Training
Training plans for the health care providers and pharmacy personnel at all levels of
the health system, including training of trainers
Determine the minimum number of trainers and supervisors required for the training
of health workers for the piloting and roll-out of the new guidelines.
Training on monitoring and evaluation
Task shifting plan to ensure that ARV drugs for treatment can be dispensed in
facilities where PMTCT activities are carried out
Identification of health facilities for piloting the new guidelines
A plan for phased roll-out of the new guidelines, including data on targeted populations by region or health facility
Procurement & Supply Chain Management
Piloting and roll-out
7
5
Quantification and forecasting and procurement
(for the first 5 years)
National quantification and forecasting of the commodities, including pharmaceuticals and diagnostic laboratory commodities, if possible disaggregated by region,
level of care or health facility
Procurement plan and budget for the first year, and the first 3-5 years
Availability of funds and funding sources
List of key PMTCT commodities for Option B+
Laboratory reagents and supplies:
◦◦ Rapid tests
◦◦ CD4
◦◦ EID
ARVs:
◦◦ Mothers: fixed-dose combination of the preferred regimen (e.g., TDF/3TC/EFV)
and the alternative regimens (e.g., AZT/3TC+EFV) for ART
◦◦ Babies: NVP syrup or NVP dispersible
Opportunistic infections (OIs):
◦◦ Co-trimoxazole prophylaxis for mothers and babies
Maternal Health commodities:
◦◦ Standard list of micronutrients for ANC attendants
Procurement & Supply Chain Management
◦◦ Diagnostic kits and laboratory reagents required for routine monitoring in ANC
8
Distribution plans
Initial distribution plans by facility
Maximum and minimum stock levels agreed for each facility and distribution point
Re-supply distribution plans, depending on whether pull or push system is planned
An appropriate distribution system for the commodities, if necessary, identification
of potential agencies for out sourcing
5
Monitoring and evaluation plans and tools
5.5 Key Resources: Links to Tools
General procurement and supply chain management tools
• PSM Toolbox: www.psmtoolbox.org
WHO early warning indicators to prevent stock-outs
• http://whqlibdoc.who.int/publications/2011/9789241500814_eng.pdf
ARV forecasting & quantification (these tools may need to be adapted somewhat
for Option B+)
• CHAI ARV Procurement Forecasting Tool: http://www.psmtoolbox.org/en/
tool-details%7CQuantification%7CCHAI-ARV-Procurement-Forecasting-Tool%7C74
• Quantimed: http://www.msh.org/projects/sps/Resources/Software-Tools/
Quantimed.cfm
• Other tools: To be uploaded as and when they become available
Tools available to support facility-level commodity monitoring
Most countries have tools for monitoring the consumption, quantities issued and overall stock levels of ARVs and other key supplies. In Option B+, they can be adjusted to
include any items to ensure that PMTCT commodities are well covered.
For countries which do not yet have a tool in use, several tools from various partners are
found in the PSM Toolbox (see point 1 above). Using “stock” as a key search word, at
least 47 tools will be found.
Procurement & Supply Chain Management
9